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The overall (cross-sectional) objective of this study is to detect and describe the profile of AD-related blood biomarkers in a population with SCD (including individuals with MCI) with the ultimate goal of investigating their capacity to predict underlying AD pathology. Longitudinally, the β-AARC_BBRC2021 study fundamentally aims at assessing the ability of AD-related blood-based biomarkers to predict disease progression in the Alzheimer's continuum.
To achieve these cross-sectional and longitudinal objectives, an exhaustive set of clinical, risk factors, cognitive, mental health and neuroimaging data will be collected, as well as blood and CSF samples, from which AD-related fluid biomarkers will be determined.
As a secondary objective, we will investigate the efficacy and accuracy of the Altoida NMI as a novel digital biomarker for identifying patients with SCD or MCI that have underlying AD pathology (cross-sectionally) and to test the capacity of the Altoida NMI to track disease progression in these popoulations (longitudinally).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjective cognitive decline | Male and female, aged 55 to 80 years with subjective cognitive decline, either cognitively unimpaired or with mild cognitive impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | Cross sectional analyses The two main variables for the analysis will be: Values of biomarker concentrations in blood and their correlations with CSF biomarkers and the development of prodromal AD for the cognitively unimpaired SCD population. Other variables of interest for the study are, among others, risk factors, cognitive status, measurements of brain structure and function, mental health, chronic diseases, environmental exposures, age and sex. Longitudinal analyses Longitudinal analyses will estimate the association between the intensity of the subjective complaint and the rate of progression between the diagnostic categories; The association of biomarkers, risk factors and other clinical variables with the rate of progression between the diagnostic categories; The association of cognitive and neuroimaging variables with the rate of progression between the diagnostic categories; The evolution of the complaint itself and its relation to the other variables described. |
| Measure | Description | Time Frame |
|---|---|---|
| CSF Aβ42/Aβ40 ratio | The capacity of plasma biomarkers to predict (alone or in combination of covariates) Alzheimer's pathology | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cost effectiveness | The ratio between the cost and predictive capacity of these variables will be considered to derive a triaging algorithm for primary care | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Two-hundred participants, aged 55 to 80 years with subjective cognitive decline, will be primarily selected from the population seeking medical advice on their cognitive performance to Primary care units. In addition, other conventional recruitment strategies may be used (e.g. participants of ongoing or ended BBRC-sponsored studies,novel recruitment calls…).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BarcelonaBeta Brain Research Center | Barcelona | Barcelona | 08005 | Spain |
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|
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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